Effect of Task-Specific Training in Augmented Reality Context (INTERACT Protocol) on Upper Limb Function and Activities in Children With Spastic Cerebral Palsy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Kinematic assessment of manual reach
研究概览
简要总结
Children with Cerebral Palsy (CP), a condition that affects movement and coordination, face difficulties in daily activities such as dressing, reaching for objects in high places, and getting up from seats. These challenges can negatively impact the quality of life for these children. Therefore, it is essential to seek effective treatments that help improve these skills.
The use of technology in treatments, especially with games that utilize augmented reality (AR), has proven to be a good strategy. This technique aids motor learning, improving the skills that children struggle with while also increasing motivation, allowing them to engage in activities they enjoy. However, the application of AR in children with CP is still limited.
In this context, it is crucial to provide appropriate treatments for these children, harnessing the benefits of AR technology. This study aims to investigate the effects of a protocol called "INTERACT protocol," which consists of training activities that interest children, such as reaching for objects and getting up from a bench. These activities are linked to AR games and will be conducted with accessible equipment for children with CP, aiming to improve their quality of life.
The children selected for the research will be divided into two groups: the experimental group (INTERACT) and the control group. This division will be done by random draw. The children in the control group will continue receiving the physiotherapy they are already undergoing for the same duration as the children in the INTERACT group. All children will participate in the treatment for 4 weeks, three times a week, with sessions lasting 1 hour and 20 minutes each.
Our hypothesis is that the children participating in the INTERACT protocol will show improvements in activities involving reaching for objects and in the transition from sitting to standing.
详细描述
Cerebral Palsy (CP) is defined as a group of permanent disorders of movement and posture development, caused by non-progressive brain injuries to the fetal or developing brain. The prevalence is 2.3 to 3.7 per thousand children born in low- and middle-income countries, and 1.6 to 2.9 per thousand children in developed countries.
The motor impairments present in children with CP are considered more complex in the upper limbs and are represented by changes in proprioception, selective motor control, presence of spasticity, reduced range of joint motion, muscle strength, and motor coordination deficits. These cited structural and functional impairments lead to limitations in the execution of activities, such as reaching and grasping, object manipulation, and activities of daily living.
Knowing that children with CP present deficiencies in upper limb motor function, it is important to carry out appropriate interventions. In this case, physiotherapy plays an important role in the rehabilitation of children with CP, but it is necessary to implement highly recommended approaches. The literature points to the level of evidence for improving motor function and task performance in children and adolescents with CP, highlighting specific task training, which is indicated with a green signal of scientific evidence and strong strength of recommendation.
Thus, rehabilitation for the recovery of function and motor activities involving the upper limbs of children with CP should focus on the practice of specific tasks used in daily life and real environments that are goal-directed. However, recent recommendations indicate that auxiliary interventions, when combined with specific task training, present better results. A new form of intervention that is expanding technology for rehabilitation and can be associated with specific task training is augmented reality (AR) therapy. AR has become an effective intervention strategy because it promotes motivation and interaction between the real world and the digital content universe, where both complement each other. It has been reported that AR training improves motor skills and provides the opportunity for low-cost rehabilitation, which can also be carried out at home. However, it is important to highlight that studies on AR are scarce and reveal gaps in the literature that need to be filled.
Given the need to fill these gaps, the objective of this study is to verify the effects of a specific task training protocol associated with augmented reality (INTERACT protocol) on the function and activities of the upper limbs in children diagnosed with spastic cerebral palsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The study will be single-blind, meaning that the evaluator will not know the group to which the participant is assigned. Additionally, in the statistical analysis, the examiner will also remain blind regarding the type of intervention, referring to them as intervention 1 and intervention 2. However, the participants will not be blind to the treatments, due to the impossibility of blinding the type of intervention they will receive.
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In the experimental and control groups, children who have been medically diagnosed with cerebral palsy, either unilateral or bilateral, with spasticity classification, will be included.
- •Participants must be classified at GMFCS levels I and II, meaning they are capable of walking independently.
- •The MACS (Manual Ability Classification System) should be between levels I (manipulates objects easily), II (manipulates most objects with reduced quality and speed), and III (manipulates objects with difficulty).
- •The modified Ashworth score should be between 0 and
- •Ability to understand verbal commands and good comprehension of the proposed games.
排除标准
- •Children with dystonic tone classification (identified by the Hypertonia Assessment Tool (HAT)), athetoid, or ataxic.
- •GMFCS levels III, IV, and V.
- •MACS levels IV and V.
- •Modified Ashworth score of 3 to
- •Undergoing orthopedic surgical procedures within the past year.
- •Receiving chemical blocks within the last 6 months.
- •Deformities (muscle shortening and/or loss of joint mobility in the upper limbs) that prevent or compromise the ability to reach the midline.
- •Presence of visual and/or auditory sensory deficits not corrected with devices.
- •Use of medications that may alter muscle strength or tone.
- •Cardiovascular limitations of any intensity, such as excessive fatigue, low exercise tolerance.
- •Children who have undergone other intensive therapies within the past 6 months.
- •Children with cognitive impairment indicated by caregivers or perceived by researchers due to difficulties in understanding verbal commands and virtual reality games.
- •Children who do not accept playing augmented reality games.
结局指标
主要结局
Kinematic assessment of manual reach
时间窗: Initial assessment (two days before the intervention); final assesment (maximum five days after the intervention);retention phase assessment (two months after the end of the intervention).
Data collection of reach movement will be conducted using the OpenCap software, which combines computer vision and musculoskeletal simulation to quantify human movement kinematics from videos captured using iPhones.
Disabilities of the Arm, Shoulder and Hand (DASH)
时间窗: Initial assessment (two days before the intervention); final assesment (maximum five days after the intervention);retention phase assessment (two months after the end of the intervention).
This questionnaire measures physical disability and symptoms in single or multiple upper limb disorders. The DASH requires that the participant answers the questions based on their perceived condition from the previous week. If the participant did not have the opportunity to perform any of the activities in the questionnaire, they are instructed to estimate which response would be the most accurate. It does not matter which hand or arm is used to perform the activity; the questions should be answered based on the ability, regardless of how the task is performed. Participants must respond by circling the answers from 1 to 5, where 1 = there was no difficulty and 5 = could not do it. The higher the score, the greater the motor inability to perform daily activities involving upper limbs.
Assessment of postural sway during the sit-to-stand movement and during functional reach in standing position
时间窗: Initial assessment (two days before the intervention); final assesment (maximum five days after the intervention);retention phase assessment (two months after the end of the intervention).
These analyses will be performed using the force platform. Sitting to standing analysis: the child will be positioned on a height-adjustable bench with the knees, ankles and hips at a 90º angle, the upper limbs crossed and supported on the chest and the feet on the force platform in a symmetrical manner. Functional reach: on the force platform, with the lower limbs aligned at hip width, and the child should reach as far as possible, moving the center of mass forward, without taking the feet off the platform and with the shoulders flexed at 90º.
次要结局
- Goal Attainment Scaling (GAS)(Initial assessment (two days before the intervention); intermediate assessment (after two weeks of training);final assessment (maximum five days after the intervention).)
- Pediatric Evaluation of Disability Inventory (PEDI - CAT)(Initial assessment (two days before the intervention); final assesment (maximum five days after the intervention);retention phase assessment (two months after the end of the intervention).)
- Challenge Test(Initial assessment (two days before the intervention); final assesment (maximum five days after the intervention);retention phase assessment (two months after the end of the intervention).)
- The Canadian Occupational Performance Measure (COPM)(Initial assessment (two days before the intervention); final assessment (maximum five days after the intervention))
- Dimensions of Mastery Questionnaire (DMQ)(Initial assessment (two days before the intervention); final assesment (maximum five days after the intervention);retention phase assessment (two months after the end of the intervention).)
研究者
Luana Pereira Oliveira Gonçalves
Phd student
Universidade Federal de Sao Carlos